‘We are rolling out the test kits in phases’
Late last month, Mylab Discovery Solutions became the first Indian company to get commercial approval for its diagnostic test for covid-19 from the Central Drugs Standard Control Organization (CDSCO) after an evaluation by the Indian Council of Medical Research. The test kit, named the Mylab PathoDetect COVID-19 Qualitative PCR kit, was developed in a record six weeks, making its head of research and development Minal Dakhave Bhosale an instant hero as news of her working on the test till the last days of her pregnancy spread.
A young biotech firm established in 2016, Mylab has considerable expertise in manufacturing Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) tests, and this helped the biotech firm develop the covid-19 test. RT-PCR is a laboratory technique that combines the reverse transcription of RNA into DNA using a polymerase chain reaction (PCR) and is primarily used to measure the amount of specific RNA in a cell. Its ability to quantify viral RNA makes the technique one of the most common ways of identifying viral strains. “Research and manufacturing high-quality diagnostics has always been our focus. For example, we are the only Indian company with ID-NAT test approval in India (Individual Donor-Nucleic Acid Testing is used to test donor blood for HIV, hepatitis C virus and hepatitis B virus). Looking at how the novel coronavirus was spreading across the world, our research team started working on developing the test,” says Gautam Wankhede, medical affairs director, Mylab.
With government approval under its belt, Mylab is now preparing to roll out the test at scale for both government and private labs. “ICMR has provided us with a list of labs which can test using the RT-PCR technique and we are rolling out the test kits in phases. Since it is not a home kit, it can only be made available to the approved labs,” says Wankhede.
At present, Mylab can create 20,000 test kits—they are working at capacity right now. “We are working on increasing it significantly,” says the scientist.
‘It takes 7-8 years to develop a vaccine’
With nearly a million people testing positive for covid-19 and about three billion people in lockdown around the world, biotechnology and drug research companies everywhere are engaged in an unprecedented effort to develop vaccines for the pandemic.
According to the World Health Organization, two companies are at phase 1 (out of three phases) of clinical evaluation while 42 others are at a pre-trial stage. One of these 42 companies is Pune-based Serum Institute of India, run by the father-son duo Cyrus and Adar Poonawalla. The institute is working in collaboration with Codagenix, a US-based biotechnology company.
“This collaboration happened because Codagenix has an algorithm to produce any virus at a rapid speed,” says Adar Poonawalla, CEO of the Serum Institute, on email. “For example, we already have potential candidates to go into animal studies for the latest coronavirus outbreak.”
“It takes typically seven-eight years to develop a vaccine,” he adds, citing the examples of the vaccines his company had developed for pneumonia and rotavirus. “It takes that much time because of animal studies, human studies and also establishing when you make a strain…it is safe to use in humans. Hopefully in six months we should be able to enter into human trials.”
Human trials are typically conducted in three stages: the first involves a few dozen people, the second a few hundred and the third a few thousand. The aim is to spot the long-term side effects and weed out vaccine candidates that are unsafe or ineffective. If successful, the Serum Institute hopes to roll out its products by 2022.
Companies like the Serum Institute have been able to make progress because of early Chinese efforts to sequence the genetic material of SARS-CoV-2 , the virus that causes covid-19. In early January, China shared that sequence with research groups around the world, enabling them to grow the live virus in controlled conditions and study its effects on humans.
Although the need for a vaccine seems urgent now, Poonawalla hopes the urgency will not wane if the disease is brought under control by the time a vaccine is manufactured and made available in the market.
“The last time we had developed a flu vaccine during the H1N1 crisis, after two years nobody wanted to take the vaccine,” he says. “This is because in India, unlike in Europe and the US, adults generally do not take the flu vaccine or any other kind of vaccine. This awareness is lacking and in India we only rush to take the cure when we get the disease. I am working on changing this mindset—prevention is better than cure, and vaccines should be taken to prevent hospitalization and treatment.”
Covid-19 not a ‘generalized disease’ like H1N1
Akey factor in controlling and assessing the spread of covid-19 is testing. Unfortunately, the lack of proper testing kits is also a big reason why many big nations are struggling to detect and contain the spread of the virus.
But Bengaluru-based company XCyton has provided the Indian healthcare system with an in-house testing kit that can not only look for covid-19 but for nine different disease-causing organisms and 13 different genes.
“It’s a multiplex PCR test,” says XCyton’s founder and managing director B.V. Ravi Kumar. “This is a hospital-based test which takes roughly 5-6 hours—from sample preparation to giving a report. The samples can be nasal swabs, throat swabs or even a lung sample taken during a bronchoscopy. Anything will work,” he says over the phone.
Ravi Kumar explains that the test is meant for people who come to hospitals with respiratory illnesses. “You can test them for covid, and all non-covid conditions are followed up with serological tests. Only if they don’t seroconvert beyond 12 days of illness, then they can be sent home,” he explains. The test has been capped at ₹4,500 as per Indian Council of Medical Research (ICMR) testing guidelines. Ravi Kumar says the company will send the kits for regulatory approval to the National Institute of Virology, Pune, in the coming days .
The molecular diagnostics company’s business focuses entirely on critical care. For instance, patients who go into the ICU with infections. Given its focus on clinician agnostic tests, the covid-19 testing kit is part of recent efforts to shift to patient-and physician-centric tests.
One of the key issues, Ravi Kumar says, during the development of the testing kit was the lack of samples. This is not a “generalized disease” like H1N1 where every hospital had some positive samples, he says. In this case, all the samples were with the ICMR. “We have enough samples of influenza, rhinoviruses, all of them, but not covid-19…. Even though we had the test ready by the third week of January, it took time to obtain plasmids from various Chinese companies and test and say that it was working for covid-19…. It’s the lack of samples that was the big problem all over,” he adds.
Once the regulatory approvals are in place, Ravi Kumar says it would be possible to conduct a few hundred thousand tests in a year, depending on demand. “Right now, we are not geared up for millions of tests. A few lakh is a very big number for this stage of illness and I hope the country never needs more than that.”